Medicure Inc. (“Medicure” or the “Company”) (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce that through its subsidiary, Medicure International Inc., it has acquired the ownership of ZYPITAMAGTM (pitavastatin) tablets, from Cadila Healthcare Ltd., India (“Zydus”) for US and Canadian markets. Under terms of the agreement, Zydus will receive an upfront payment of U.S. $5,000,000 and U.S. $2,000,000 in deferred payments to be made over the next four years, as well as contingent payments on achievement of milestones and royalties related to net sales.
Medicure previously had acquired U.S. marketing rights with a profit-sharing arrangement. With this acquisition Medicure retains all profits, with full control of marketing and pricing negotiation.
ZYPITAMAGTM is a HMG-CoA reductase inhibitor indicated for adult patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet, to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) (see additional safety information provided below).
ZYPITAMAGTM was approved in 2017 by the U.S. Food and Drug Administration for sale and marketing in the United States and was launched by Medicure in the second quarter of 2018 through a license agreement it had entered into with Zydus.
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“This acquisition of ZYPITAMAGTM fits well with Medicure’s mission of being a significant cardiovascular company focused on the U.S. market,” commented Medicure’s CEO, Dr. Albert D. Friesen. “We look forward to growing the ZYPITAMAGTM brand as part of our portfolio of cardiovascular products.”
Important Safety Information for ZYPITAMAGTM (pitavastatin) tablets
Indications and Usage
Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate.
Primary Hyperlipidemia and Mixed Dyslipidemia: Zypitamag™ is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia.
Limitations of Use: Doses of Zypitamag™ greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of Zypitamag™. The effect of Zypitamag™ on cardiovascular morbidity and mortality has not been determined. Zypitamag™ has not been studied in Fredrickson Type I, III, and V dyslipidemias.
Zypitamag™ is contraindicated in patients with a known hypersensitivity to product components, in patients with active liver disease (which may include unexplained persistent elevations in hepatic transaminase levels), in women who are pregnant or may become pregnant, in nursing mothers or in coadministration with cyclosporine.
WARNINGS & PRECAUTIONS
Skeletal Muscle Effects: Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including pitavastatin.
- These risks can occur at any dose level, but increase in a dose-dependent manner, with advanced age (≥ 65 years), renal impairment, and inadequately treated hypothyroidism; administer with caution in these patients, or when used concomitantly with fibrates or lipid-modifying doses of niacin, or colchicine. Avoid concomitant administration with gemfibrozil.
- Advise patients to promptly report unexplained and/or persistent muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever; discontinue Zypitamag™.
- If muscle signs and symptoms persist after discontinuation, this may be a sign of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy associated with statin use, requiring immediate medical attention. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.
- Zypitamag™ should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected.
- Zypitamag™ should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures).
Liver Enzyme Abnormalities:
- Persistent elevation in hepatic transaminases can occur. Check liver enzymes before initiating therapy and if signs or symptoms of liver injury occur; advise patients to report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
- Fatal and non-fatal hepatic failure can occur. Interrupt Zypitamag™ if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs. If an alternate etiology is not found do not restart Zypitamag™.
- Use Zypitamag™ with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease. Do not use Zypitamag™ if patient has active liver disease, which may include unexplained persistent transaminase elevations.
- Increases in HbA1c and fasting serum glucose levels have been reported.
COMMON ADVERSE REACTIONS
Myalgia, back pain, diarrhea, constipation and pain in extremity (rate ≥ 2% in at least one marketed dose). This is not a complete list of all reported adverse events.
For additional information, refer to full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Date: October 07, 2019
Source: PR Newswire